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Temozolomide in Treating Patients With Brain Metastases

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Duke University Identifier:
First received: July 5, 2000
Last updated: June 19, 2013
Last verified: October 2009

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.

Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: temozolomide Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Brain Metastases With Temodar

Resource links provided by NLM:

Further study details as provided by Duke University:

Study Start Date: August 2000
Study Completion Date: June 2003
Detailed Description:


  • Determine the activity of temozolomide in patients with brain metastases.
  • Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Metastatic lesions to the brain

    • Must not require immediate radiotherapy
    • If received prior radiotherapy, must have progressive disease
  • Evaluable disease by CT scan or MRI
  • Neurologically stable



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN


  • Blood urea nitrogen less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent nonmalignant systemic disease
  • No acute infection requiring treatment with IV antibiotics
  • HIV negative
  • No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow)


Biologic therapy:

  • No concurrent hematopoietic growth factors, including epoetin alfa
  • No other concurrent biologic therapy


  • At least 4 weeks since prior chemotherapy, unless evidence of disease progression
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered


  • No other concurrent investigational drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005954

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
  More Information

Responsible Party: Henry Friedman, MD, Duke UMC Identifier: NCT00005954     History of Changes
Other Study ID Numbers: 2114
CDR0000067934 ( Other Identifier: NCI )
Study First Received: July 5, 2000
Last Updated: June 19, 2013

Keywords provided by Duke University:
adult tumors metastatic to brain

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on June 23, 2017